BOSTON SCIENTIFIC CORPORATION · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1993
Total Reports
3,297
Reports (30d)
49
Active Signals
2
Open Recalls
4
What the reports describe · Claripulse analysis
High Shock Impedance Measurements
defibrillator crt, cardiac resynchronization, crt, remains service, effects
71
reports
Right Lead Revision for Infection
explanted right, infection additional, effects, reported lead, revision infection
8
reports
High Shock Impedance Measurements on ICD
measurements, icd, shock impedance, cardioverter defibrillator, defibrillator icd
7
reports
Out-of-Range Shock Impedance Measurements
impedance measurements, measurements, shock impedance, ohms, range shock
6
reports
Explanted Lead for Unknown Reason
effects, reported right, additional adverse, explanted replaced, new lead
6
reports
High Shock Impedance Leading to Revision
high range, effects, additional adverse, range shock, impedance measurements
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Evidence
Lack of interference between small bowel capsule endoscopy and implantable cardiac defibrillators: an 'in vivo' electrophysiological study.
Moneghini D, et al. · 2015
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.
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